Sheldon T. Bradshaw

Partner

Contact

  • Washington, DC
    p202.955.1575
    f202.778.7418
  • Washington, DC
    p202.955.1575
    f202.778.7418

Sheldon's practice focuses on providing clients with regulatory and compliance, transactional, advocacy, and litigation support with products regulated by the Food and Drug Administration.

Sheldon is co-chair of the firm's food and drug practice group. His practice focuses on providing legal and regulatory assistance to both small growth companies and large multinational corporations regarding products regulated by the Food and Drug Administration.

Prior to joining Hunton & Williams, Sheldon served as Chief Counsel at the U.S. Food and Drug Administration (FDA) from 2005 to 2007. As Chief Counsel, he was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA's senior leadership—including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers—on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA and every significant warning letter issued by the FDA. Prior to his service at the FDA, Sheldon held several senior positions at the U.S. Department of Justice where he, among other things, provided advice to FDA and testified before Congress on matters under the FDA's jurisdiction. At the firm, he advises clients in the same areas in which he worked while Chief Counsel of FDA.

From 1996 to 1999, Sheldon was a law clerk for the Hon. Karen J. Williams of the United States Court of Appeals for the Fourth Circuit. He is admitted to practice before the United States Court of Appeals for the Fourth and Fifth Circuits.

Relevant Experience

  • Advised numerous pharmaceutical companies on drug approval strategies involving new drug applications, 505(b)(2) applications, suitability petitions, and abbreviated new drug applications (ANDAs).
  • Counseled clients regarding product life cycle management (including the development of new products and line extensions), Hatch-Waxman issues (including patent and non-patent exclusivities, 30-month stays and FDA's Orange Book); user fees, and risk evaluation and mitigation strategies (REMS).
  • Assisted pharmaceutical companies and device manufacturers with post-approval issues, including labeling changes, adverse event reporting, good manufacturing practice requirements (GMPs), and promotional activities.
  • Helped clients respond to, and recover from, Warning and Untitled Letters sent by FDA.
  • Advised device manufacturers on 510(k) and pre-market approval (PMA) applications.
  • Advised clients regarding "intended use" and the types of claims that distinguish drugs and devices from cosmetics, dietary supplements and food.
  • Reviewed labeling of drugs, both Rx and OTC, devices, dietary supplements, food, and cosmetics for compliance with the FD&C Act.
  • Counseled clients on legal issues related to the design and implementation of clinical trials, including the preparation of investigational new drug (IND) applications and investigational device exemption (IDE) applications and the submission of information to the clinical trial registry and the new clinical trial results database.
  • Provided clients with crisis management counseling on product recalls, government inspections and seizures, adverse events, and similar issues.
  • Advised clients on issues related to the practices of medicine and pharmacy.
  • Represented companies in interactions with regulatory officials from the FDA.
  • Assisted companies in criminal, civil, and administrative enforcement actions and related civil litigation involving health care fraud and abuse, qui tam lawsuits, preemption, off-label promotion, misbranding, adulteration, and the anti-kickback statute.
  • Advised clients on issues related to pharmacy compounding and the distinction between traditional pharmacy compounding and manufacturing.
  • Retained as an expert witness in lawsuit involving allegations that the advertising for a grandfathered drug product was false or misleading.
  • Retained as an expert witness in lawsuit involving allegations that the advertising for a cosmetic rendered the product a drug under the FD&C Act.
  • Retained as an expert witness in lawsuits involving FDA's juice labeling regulations.
  • Retained as an expert witness in lawsuit involving FDA's review of proprietary drug names.
  • Retained as an expert witness in lawsuit involving animal drug compounding.
  • Advised a major pharmaceutical company subject to FDA's Application Integrity Policy.
  • Counseled a client importing food products that were subject to a country-wide Import Alert.
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